Safety Research and Evaluation

Drug safety research and evaluation, also known as non-clinical drug safety evaluation, refers to the evaluation of the safety of therapeutic drugs through laboratory studies and animal in vitro systems. It is a necessary procedure and important step before new drugs enter clinical trials and are finally approved.

Non-clinical drug safety evaluation mainly involves animal experiments, including general toxicology studies, stimulation tests, allergy tests, hemolysis tests, developmental and reproductive toxicology, genetic toxicity, immunotoxicity, safety pharmacology, toxicokinetic studies, etc. After this series of experiments yields valid results, the drug can enter clinical trials. Drug safety research and evaluation is a necessary measure to strengthen drug safety monitoring and ensure public drug safety.

STEMart provides comprehensive drug safety research and evaluation services to ensure that new drugs comply with industry standards and regulations, laying the foundation for further clinical testing of drugs.

Test Samples

Various new drugs

Test Items

• Single dose toxicity test
  • Single dose toxicity test in rodents
  • Single dose toxicity test in non-rodents
• Repeated dose toxicity test
  • Experimental species include mice, rats, dogs, non-human primates, etc.
  • Administration methods include oral administration, injection administration, percutaneous administration, etc.
• Developmental and reproductive toxicity test
  • Fertility and early embryonic development toxicity test
  • Embryo-fetal developmental toxicity and maternal function test
  • Perinatal developmental toxicity and maternal function test
• Genotoxicity test
  • AMES test
  • Chromosome aberration test
  • Micronucleus test
• Local toxicity test
  • Irritation test (vascular irritation, muscle irritation, skin irritation, mucosal irritation, phototoxicity of skin administration, etc.)
  • Allergy test (active systemic allergy, active skin allergy, passive skin allergy, skin photoallergic reaction, etc.)
  • Hemolytic test
• Immunogenicity test
• Safety pharmacological test (rats, mice, dogs, non-human primates)
  • Central nervous system test (mouse general behavior test, mouse spontaneous activity test, mouse rotating rod test, mouse subliminal hypnosis test, etc.)
  • Cardiovascular system test (changes in blood pressure, ECG and other indicators before and after the dose)
• Toxicokinetic test
• Carcinogenic test

For more information about our drug safety research and evaluation services, please contact us.